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| ID | Type | Description | Link |
|---|---|---|---|
| 205593 | Other Grant/Funding Number | Consortium of Multiple Sclerosis Centers |
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| Name | Class |
|---|---|
| Consortium of Multiple Sclerosis Centers | OTHER |
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The Primary Aim of this research study is to determine the feasibility of 8 weeks of physical therapy strengthening exercises using blood flow restriction (BFR) in people with multiple sclerosis (MS) who have moderate-to-severe walking problems. BFR training involves placing a cuff on the leg being exercised in order to restrict blood flow. The cuff is attached to a specialized device that automatically detects the appropriate amount of pressure to place on the limb. Testing will occur before and after the 8-week treatment period.
The Primary Aim of this research study is to determine the feasibility of 8 weeks of physical therapy strengthening exercises using blood flow restriction (BFR) in people with multiple sclerosis (MS) who have moderate-to-severe walking problems. BFR training involves placing a cuff on the leg being exercised in order to restrict blood flow. The cuff is attached to a specialized device that automatically detects the appropriate amount of pressure to place on the limb. Testing will occur before and after the 8-week treatment period.
Specific Aim 1: Determine the feasibility of BFR by assessing recruitment rate, retention, adherence, satisfaction, and safety.
Hypothesis: Feasibility will be demonstrated by: 1) enrolling 20 participants in 8 months, 2) retaining at least 16 (80%) participants, 3) 80% adherence to intervention, 4) 90% satisfaction with intervention, and 5) no serious adverse events related to the intervention.
Specific Aim 2: Determine changes in knee and hip extension, hip abduction, and ankle plantarflexion muscle strength after the 8-week intervention.
Hypothesis: Following intervention there will be clinically important within-group strength changes that correspond to established minimal detectable change values and which can be characterized as having at least a moderate effect size as defined by Cohen's d.
Exploratory Aim: Explore changes in functional mobility (30-Second Sit-to-Stand, Berg Balance Scale, Timed 25-Foot Walk. 10-day average activity level) and self-report measures (12-Item MS Walking Scale, Modified Fatigue Impact Scale, MS Impact Scale-29, and Patient-Specific Functional Scale) after the 8-week intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood Flow Restriction Exercise | Experimental | Participant will participate in a supervised low load blood flow restriction exercise program twice a week for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Flow Restriction Exercise | Other | Following a 5-minute low intensity warm-up, the BFR cuff will be placed at the most proximal portion of the leg and dosed following standard BFR guidelines: 1 set of 30 reps, then 3 sets of 15 reps at 20-30% 1RM with up to 80% limb occlusion. Exercises will target bilateral 1) knee and hip extension, 2) hip abduction, and 3) ankle plantarflexion, as these muscles are important for functional mobility in people with MS. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Knee Extension Muscle Strength (More-involved Side) | Knee extension muscle strength measured by hand-held dynamometry on the more-involved side. The more-involved limb was determined at baseline assessment and defined as the limb with worse muscle strength. | Measured at Baseline (Week 0) and Post Test (Week 9) |
| Change in Hip Abduction Muscle Strength (More-involved Side) | Hip abduction muscle strength measured by hand-held dynamometry on the more-involved side. The more-involved limb was determined at baseline assessment and defined as the limb with worse muscle strength. | Measured at Baseline (Week 0) and Post Test (Week 9) |
| Change in Ankle Plantarflexion Muscle Strength (More-involved Side) | Ankle plantarflexion muscle strength measured by hand-held dynamometry on the more-involved side. The more-involved limb was determined at baseline assessment and defined as the limb with worse muscle strength. | Measured at Baseline (Week 0) and Post Test (Week 9) |
| Change in Knee Extension Muscle Strength (Less-involved Side) | Knee extension muscle strength measured by hand-held dynamometry on the less-involved side. The less-involved limb was determined at baseline assessment and defined as the limb with better muscle strength. | Measured at Baseline (Week 0) and Post Test (Week 9) |
| Change in Hip Abduction Muscle Strength (Less-involved Side) | Hip abduction muscle strength measured by hand-held dynamometry on the less-involved side. The less-involved limb was determined at baseline assessment and defined as the limb with better muscle strength. | Measured at Baseline (Week 0) and Post Test (Week 9) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 30-second Sit-to-stand Completions | Functional mobility test measuring the number of sit to stand cycles a participant can complete in 30 seconds | Measured at Baseline (Week 0) and Post Test (Week 9) |
| Change in Berg Balance Scale |
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Inclusion Criteria:
Adults ages 18-70
Neurologist-confirmed diagnosis of multiple sclerosis
Expanded Disability Status Scale (EDSS) 6.0 to 7.0
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark M Manago, PT, DPT, PhD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36897202 | Derived | Manago MM, Cohen ET, Cameron MH, Christiansen CL, Bade M. Reliability, Validity, and Responsiveness of the Patient-Specific Functional Scale for Measuring Mobility-Related Goals in People With Multiple Sclerosis. J Neurol Phys Ther. 2023 Jul 1;47(3):139-145. doi: 10.1097/NPT.0000000000000439. Epub 2023 Mar 7. |
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Participants were pre-screened over the telephone prior to baseline testing. Enrollment occurred upon signing of the consent form at the beginning of the baseline testing session. Participants were then fully screened to determine final inclusion status prior to beginning intervention.
Participant recruitment occurred in collaboration with the UCHealth Movement Disorders Clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Blood Flow Restriction Exercise | Participant will participate in a supervised low load blood flow restriction exercise program twice a week for 8 weeks. Blood Flow Restriction Exercise: Following a 5-minute low intensity warm-up, the BFR cuff will be placed at the most proximal portion of the leg and dosed following standard BFR guidelines: 1 set of 30 reps, then 3 sets of 15 reps at 20-30% 1RM with up to 80% limb occlusion. Exercises will target bilateral 1) knee and hip extension, 2) hip abduction, and 3) ankle plantarflexion, as these muscles are important for functional mobility in people with MS. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Sixteen participants were enrolled in the study. One participant withdrew consent prior to completing baseline information. One participant was screened after consenting, but prior to completing baseline information.
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| ID | Title | Description |
|---|---|---|
| BG000 | Blood Flow Restriction Exercise | Participant will participate in a supervised low load blood flow restriction exercise program twice a week for 8 weeks. Blood Flow Restriction Exercise: Following a 5-minute low intensity warm-up, the BFR cuff will be placed at the most proximal portion of the leg and dosed following standard BFR guidelines: 1 set of 30 reps, then 3 sets of 15 reps at 20-30% 1RM with up to 80% limb occlusion. Exercises will target bilateral 1) knee and hip extension, 2) hip abduction, and 3) ankle plantarflexion, as these muscles are important for functional mobility in people with MS. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Knee Extension Muscle Strength (More-involved Side) | Knee extension muscle strength measured by hand-held dynamometry on the more-involved side. The more-involved limb was determined at baseline assessment and defined as the limb with worse muscle strength. | Posted | Mean | 95% Confidence Interval | kg | Measured at Baseline (Week 0) and Post Test (Week 9) |
|
Adverse Event data was collected across the 10 weeks of study participation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Blood Flow Restriction Exercise | Participant will participate in a supervised low load blood flow restriction exercise program twice a week for 8 weeks. Blood Flow Restriction Exercise: Following a 5-minute low intensity warm-up, the BFR cuff will be placed at the most proximal portion of the leg and dosed following standard BFR guidelines: 1 set of 30 reps, then 3 sets of 15 reps at 20-30% 1RM with up to 80% limb occlusion. Exercises will target bilateral 1) knee and hip extension, 2) hip abduction, and 3) ankle plantarflexion, as these muscles are important for functional mobility in people with MS. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Edema Limbs | General disorders | CTCAE (5.0) | Systematic Assessment |
With a small sample and no control group we cannot conclude that the BFR was the cause of these changes.
The entire study sample identified as Caucasian and non-Hispanic and therefore may not be as generalizable to other races and/or ethnicities.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Manago | University of Colorado Denver, Anschutz Medical Campus | 303-724-9101 | mark.manago@cuanschutz.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 15, 2020 | Nov 7, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 13, 2020 | Nov 4, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D000090003 | Blood Flow Restriction Therapy |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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|
| Change in Ankle Plantarflexion Muscle Strength (Less-involved Side) | Ankle plantarflexion muscle strength measured by hand-held dynamometry on the less-involved side. The less-involved limb was determined at baseline assessment and defined as the limb with better muscle strength. | Measured at Baseline (Week 0) and Post Test (Week 9) |
Functional mobility test measuring the participant's ability to balance in different postures. Scores on the Berg Balance Scale range from 0 to 56 points, with 0-20 points indicating wheelchair bound, 21-40 indicating walking with assistance, and 41-56 indicating walking independently.
| Measured at Baseline (Week 0) and Post Test (Week 9) |
| Change in Timed 25-foot Walk | Functional mobility test measuring the time it takes a participant to walk 25 feet | Measured at Baseline (Week 0) and Post Test (Week 9) |
| Change in Activity Level | 10-day average of activity level as measured by a wearable activity monitor | Measured at Baseline (Week 0) and Post Test (Week 9) |
| Change in 12-Item MS Walking Scale | Self-report questionnaire measuring walking ability with scores ranging from 12 points (no difficulty walking, to 60 points (extremely limited or no walking) | Measured at Baseline (Week 0) and Post Test (Week 9) |
| Change in Modified Fatigue Impact Scale | Self-report questionnaire measuring fatigue caused by MS with scores ranging from 0 (no impact of fatigue in the past 4 weeks) to 84 (maximum impact of fatigue in the past 4 weeks) | Measured at Baseline (Week 0) and Post Test (Week 9) |
| Change in MS Patient-Specific Function Scale | Self-report questionnaire measuring the ability of the participant to do three self-identified activities. Scores of each of the 3 activities range from 0 (unable to perform) to 10 (able to perform without difficulty). The score is the average of the 3 activities, with higher scores indicating better function. | Measured at Baseline (Week 0) and Post Test (Week 9) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Expanded Disability Status Scale | The EDSS is a 0-10 scale, in 0.5-unit increments, used to quantify Multiple Sclerosis (MS) disability, primarily focusing on walking ability. Higher scores indicate higher disability. | Mean | Standard Deviation | units on a scale |
|
|
|
| Primary | Change in Hip Abduction Muscle Strength (More-involved Side) | Hip abduction muscle strength measured by hand-held dynamometry on the more-involved side. The more-involved limb was determined at baseline assessment and defined as the limb with worse muscle strength. | Posted | Mean | 95% Confidence Interval | kg | Measured at Baseline (Week 0) and Post Test (Week 9) |
|
|
|
| Primary | Change in Ankle Plantarflexion Muscle Strength (More-involved Side) | Ankle plantarflexion muscle strength measured by hand-held dynamometry on the more-involved side. The more-involved limb was determined at baseline assessment and defined as the limb with worse muscle strength. | Posted | Mean | 95% Confidence Interval | kg | Measured at Baseline (Week 0) and Post Test (Week 9) |
|
|
|
| Primary | Change in Knee Extension Muscle Strength (Less-involved Side) | Knee extension muscle strength measured by hand-held dynamometry on the less-involved side. The less-involved limb was determined at baseline assessment and defined as the limb with better muscle strength. | Posted | Mean | 95% Confidence Interval | kg | Measured at Baseline (Week 0) and Post Test (Week 9) |
|
|
|
| Primary | Change in Hip Abduction Muscle Strength (Less-involved Side) | Hip abduction muscle strength measured by hand-held dynamometry on the less-involved side. The less-involved limb was determined at baseline assessment and defined as the limb with better muscle strength. | Posted | Mean | 95% Confidence Interval | kg | Measured at Baseline (Week 0) and Post Test (Week 9) |
|
|
|
| Primary | Change in Ankle Plantarflexion Muscle Strength (Less-involved Side) | Ankle plantarflexion muscle strength measured by hand-held dynamometry on the less-involved side. The less-involved limb was determined at baseline assessment and defined as the limb with better muscle strength. | Posted | Mean | 95% Confidence Interval | kg | Measured at Baseline (Week 0) and Post Test (Week 9) |
|
|
|
| Secondary | Change in 30-second Sit-to-stand Completions | Functional mobility test measuring the number of sit to stand cycles a participant can complete in 30 seconds | Posted | Mean | 95% Confidence Interval | Sit-to-stand completions | Measured at Baseline (Week 0) and Post Test (Week 9) |
|
|
|
| Secondary | Change in Berg Balance Scale | Functional mobility test measuring the participant's ability to balance in different postures. Scores on the Berg Balance Scale range from 0 to 56 points, with 0-20 points indicating wheelchair bound, 21-40 indicating walking with assistance, and 41-56 indicating walking independently. | Posted | Mean | 95% Confidence Interval | score on a scale | Measured at Baseline (Week 0) and Post Test (Week 9) |
|
|
|
| Secondary | Change in Timed 25-foot Walk | Functional mobility test measuring the time it takes a participant to walk 25 feet | Posted | Mean | 95% Confidence Interval | seconds | Measured at Baseline (Week 0) and Post Test (Week 9) |
|
|
|
| Secondary | Change in Activity Level | 10-day average of activity level as measured by a wearable activity monitor | Posted | Mean | 95% Confidence Interval | Steps | Measured at Baseline (Week 0) and Post Test (Week 9) |
|
|
|
| Secondary | Change in 12-Item MS Walking Scale | Self-report questionnaire measuring walking ability with scores ranging from 12 points (no difficulty walking, to 60 points (extremely limited or no walking) | Posted | Mean | 95% Confidence Interval | score on a scale | Measured at Baseline (Week 0) and Post Test (Week 9) |
|
|
|
| Secondary | Change in Modified Fatigue Impact Scale | Self-report questionnaire measuring fatigue caused by MS with scores ranging from 0 (no impact of fatigue in the past 4 weeks) to 84 (maximum impact of fatigue in the past 4 weeks) | Posted | Mean | 95% Confidence Interval | score on a scale | Measured at Baseline (Week 0) and Post Test (Week 9) |
|
|
|
| Secondary | Change in MS Patient-Specific Function Scale | Self-report questionnaire measuring the ability of the participant to do three self-identified activities. Scores of each of the 3 activities range from 0 (unable to perform) to 10 (able to perform without difficulty). The score is the average of the 3 activities, with higher scores indicating better function. | Posted | Mean | 95% Confidence Interval | score on a scale | Measured at Baseline (Week 0) and Post Test (Week 9) |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 10 |
| 14 |
| Fall | General disorders | CTCAE (5.0) | Systematic Assessment |
|
| Muscle Strain | General disorders | CTCAE (5.0) | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
|
| COVID-19 | Infections and infestations | CTCAE (5.0) | Systematic Assessment |
|
| Hypertension | Cardiac disorders | CTCAE (5.0) | Systematic Assessment |
|
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |